Richard M Novak
University Of Illinois At Chicago
Project start date: 2007-02-01
Project end date: 2013-12-31
Sponsored Links Excellgen http://Excellgen.com
TARGETING HIGH-RISK WOMEN FOR HVTN AND MICROBICIDE TRIALS
Richard M Novak
University Of Illinois At Chicago, 310 Aob, M/c 672, Chicago, Il 60612
Grant 5U01AI069554-04 from National Institute Of Allergy And Infectious Diseases
Abstract: University of Illinois at Chicago (UIC) Project WISH (Women Invested in Stopping HIV) is applying to become a Clinical Trials Unit. We are proposing that our organization be the only Clinical Research Site for his CTU. We are currently an HIV Vaccine Trial Unit for the HIV Vaccine Trials Network (HVTN) and are proposing to continue that relationship. A letter of commitment from the HVTN leadership accompanies this application. We are also proposing to participate in the Microbicide priority research area. We do not have a network affiliation or prior agreement for this activity. In addition to current participation in the HVTN, Project WISH participated in the HIVNET Clinical Trial 014. We also provided the highest risk women (including the seroconverters) for the VaxGen VAX004 trial with an HIV incidence of 3.3% for that trial. Approximately one third of the women and one third of the African Americans in that trial came from Project WISH. This unit is also engaged in NICHD-funded HIV mucosal immunity studies in this same target population and has been included in the HVTN´s proposal to continue to investigate these issues as they relate to vaccine effectiveness. Given our access to the high-risk women, expansion of the program to include microbicide trials is appropriate. Project WISH is a free-standing research unit in the University of Illinois Medical Center. We have our own clinic which is dedicated solely to research. This clinic has several exam rooms, space for clinical trial records, and a small laboratory for the processing and storing of samples. The University of Illinois Hospital Investigational Drug Services provides pharmacy services and we have access to all of hospital laboratory services. The Principal Investigator has his own laboratory with hoods and storage facilities that are used for PBMC processing. ADMINISTRATIVE COMPONENT
Keywords: AIDS Virus; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; African American; Afro American; Afroamerican; Agreement; Area; Black Populations; Black or African American; Chicago; Clinic; Clinical Trials; Clinical Trials Unit; Clinical Trials, Unspecified; Drugs, Investigational; Funding; HIV; HIV Vaccine Trials Network; HIV vaccine; HIV/AIDS Vaccines; HOSP; HTLV-III; High Risk Woman; Hospitals; Human Immunodeficiency Viruses; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Illinois; Immunity, Mucosal; Incidence; Investigational Drugs; Investigational New Drugs; LAV-HTLV-III; Laboratories; Laboratories, Hospital; Leadership; Letters; Lymphadenopathy-Associated Virus; Medical center; Mucosal Immunity; PBMC; Peripheral Blood Mononuclear Cell; Pharmaceutical Services; Principal Investigator; Process; Programs (PT); Programs [Publication Type]; Records; Research; Research Priority; Sampling; Services; Services, Pharmaceutic; Services, Pharmacy; Target Populations; Universities; Virus-HIV; Woman; black American; clinical investigation; clinical research site; clinical site; hospital laboratories; human immunodeficiency virus vaccine; microbicidal; microbicide; programs; vaccine effectiveness; women at high risk
Project start date: 2007-02-01
Project end date: 2013-12-31
Budget start date: 1-JAN-2010
Budget end date: 31-DEC-2010
PFA/PA: RFA-AI-05-002
5U01AI069554-04 (2010): $588324
Grants awarded to Richard M Novak
Targeting High-Risk Women For HVTN And Microbicide Trials
Richard M Novak
University Of Illinois At Chicago 310 Aob, M/c 672 Chicago, Il 60612
Grant 1U01AI069554-01 from National Institute Of Allergy And Infectious Diseases IRG: ZAI1
Abstract: University of Illinois at Chicago (UIC) Project WISH (Women Invested in Stopping HIV) is applying to become a Clinical Trials Unit. We are proposing that our organization be the only Clinical Research Site for his CTU. We are currently an HIV Vaccine Trial Unit for the HIV Vaccine Trials Network (HVTN) and are proposing to continue that relationship. A letter of commitment from the HVTN leadership accompanies this application. We are also proposing to participate in the Microbicide priority research area. We do not have a network affiliation or prior agreement for this activity. In addition to current participation in the HVTN, Project WISH participated in the HIVNET Clinical Trial 014. We also provided the highest risk women (including the seroconverters) for the VaxGen VAX004 trial with an HIV incidence of 3.3% for that trial. Approximately one third of the women and one third of the African Americans in that trial came from Project WISH. This unit is also engaged in NICHD-funded HIV mucosal immunity studies in this same target population and has been included in the HVTN s proposal to continue to investigate these issues as they relate to vaccine effectiveness. Given our access to the high-risk women, expansion of the program to include microbicide trials is appropriate. Project WISH is a free-standing research unit in the University of Illinois Medical Center. We have our own clinic which is dedicated solely to research. This clinic has several exam rooms, space for clinical trial records, and a small laboratory for the processing and storing of samples. The University of Illinois Hospital Investigational Drug Services provides pharmacy services and we have access to all of hospital laboratory services. The Principal Investigator has his own laboratory with hoods and storage facilities that are used for PBMC processing. ADMINISTRATIVE COMPONENT
Keywords: antiinfective agent, clinical trial, university, AIDS vaccine, hospital, leadership, mucosal immunity, pharmacy, vaccine, clinical research
Project start date: 2007-02-01
Project end date: 2013-12-31
1U01AI069554-01 (2007): $1127790
HIV SPECIFIC IMMUNITY IN HIGHLY EXPOSED UNINFECTED WOMEN
Richard M Novak
Rush University Medical Center, 1653 W Congress Pkwy, Chicago, Il 60612
Abstract: instructions) Women from different countries who are at high-risk of HIV infection through sexual contact may be protected from infection as a result of acquired immunity to the virus. Several studies demonstrate an HIV- specific humoral immune response in the genital tract of highly exposed, uninfected women. Our hypothesis is that the local immune response in the genital tract in highly exposed seronegative (ESN) women confers protection from infection with HIV. A better understanding of this potentially protective antibody response may provide insight into the role mucosal immunity plays in preventing HIV infection and may help inform Future research related to HIV prevention in women. This goal of this project is to characterize the HIV- specific antibody response in the genital tracts of ESN women from the US and to compare their responses to those of HIV infected elite suppressors and progressors from the Women´s Interagency HIV Study (WIHS). We will determine whether the local genital antibody response is more broadly reactive in women who have been repeatedly exposed vaginally but remain uninfected. Preliminary data demonstrate that low concentrations of antibody against HIV are present in the genital fluids of more than 60% of the women in our cohort, many with reactivity against more than one pseudotype of virus. We will (1) characterize local genital tract binding and neutralizing antibodies in our cohort of high risk, seronegative women, including characterization of neutralizing antibodies that bind to broadly neutralizing epitopes (2) evaluate the durability of antibodies in the genital tract including ADCC, ADCVI and cross clade ADCC activity, (3) compare the specificity and frequency of antibodies in the genital tract of ESN women with HIV infected progressors and elite suppressors from the WIHS cohort, and (4) compare the humoral immune response in the genital tract of ESN women from Rwanda with those of ESN women from the US. It would be extremely valuable to know the particular components of the genital immune response that protect against heterosexual transmission of HIV. This knowledge could be used to develop a vaccine that effectively and selectively stimulates protective local immunity in the female genital tract against HIV infection. RELEVANCE (See instructions) Exposed seronegative women (ESN) with heterosexual exposure from multiple partners have antibodies in their genital tract against HIV. We will characterize their response and compare it to that of women who were infected following exposure. If these studies reveal differences in the types of antibodies produced by these women, it could help us understand the type of antibody needed for protection against HIV infection
Keywords: ADCC; AIDS; AIDS Seroconversion; AIDS Seropositivity; AIDS Virus; AIDS prevention; AIDS/HIV prevention; ATGN; Acquired Immune Deficiency; Acquired Immune Deficiency Syndrome; Acquired Immune Deficiency Syndrome Virus; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; Address; Adsorption; Anti-HIV Positivity; Antibodies; Antibody -dependent cell cytotoxicity; Antibody Formation; Antibody Production; Antibody Response; Antibody-Dependent Cellular Cytotoxicity; Antigenic Determinants; Antigens; Assay; Bacterial Infections; Binding; Binding (Molecular Function); Binding Determinants; Bioassay; Biologic Assays; Biological Assay; Blood Serum; Body Tissues; Cell Cytoxicity, Antibody-Dependent; Cervical; Cohort Studies; Collaborations; Concurrent Studies; Country; Data; Disease Progression; ELISA; Environment; Enzyme-Linked Immunosorbent Assay; Epitopes; Female; Focal Infection; Frequencies (time pattern); Frequency; Future; Gamma Globulin, 7S; Gene Products, RNA; Genital; Genital system; Geographic Area; Geographic Locations; Geographic Region; Geographical Location; Goals; HIV; HIV Antibody Positivity; HIV Infections; HIV Positive; HIV Positivity; HIV Prevention; HIV Seroconversion; HIV Seropositivity; HIV/AIDS prevention; HTLV-III; HTLV-III Infections; HTLV-III Seroconversion; HTLV-III Seropositivity; HTLV-III-LAV Infections; Heterosexuals; Human Immunodeficiency Viruses; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Humoral Immunities; IgA; IgG; Immune response; Immunities, Humoral; Immunity; Immunoglobulin A; Immunoglobulin G; Immunologic Deficiency Syndrome, Acquired; Individual; Infection; Instruction; Knowledge; LAV-HTLV-III; Liquid substance; Lymphadenopathy-Associated Virus; MeSH Descriptors Class 4; Measures; Mediating; Moab, Clinical Treatment; Modeling; Molecular Interaction; Monoclonal Antibodies; Mucosal Immunity; Multiple Partners; Participant; Peptides; Persons; Play; Principal Investigator; Programs (PT); Programs [Publication Type]; RNA; RNA, Non-Polyadenylated; Recruitment Activity; Research; Ribonucleic Acid; Risk; Risk Behaviors; Risky Behavior; Role; Ruanda; Rwanda; Sampling; Serum; Specificity; T-Lymphotropic Virus Type III Infections, Human; Time; Tissues; Transmission; Viral; Viral Burden; Viral Load; Viral Load result; Virus; Virus-HIV; Viruses, General; Visit; Woman; acquired immunity; antibody biosynthesis; antibody dependent cell mediated cytotoxicity; antibody positive AIDS test; antibody-based immunity; antigen positive AIDS test; at risk behavior; bacterial disease; base; cohort; cytokine; fluid; genital secretion; geographic site; gp160; high risk; host response; immunogen; immunoglobulin biosynthesis; immunoresponse; infection localized; insight; liquid; neutralizing antibody; neutralizing mAb; neutralizing monoclonal antibodies; prevent; preventing; programs; recruit; response; seropositive (AIDS test); social role; transmission process; urogenital system (genital part); vaccine development
Budget start date: 1-SEP-2010
Budget end date: 31-AUG-2011
5P01AI082971-02_7822 (2010): $360887
1P01AI082971-01_7822 (2009): $338900
Richard M Novak
University Of Illinois At Chicago
Project start date: 2007-02-01
Project end date: 2013-12-31